Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 6/27/2025
Class: II

PRODUCT

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915

Recall Number:

Z-2038-2025

REASON:

A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

RECALLING FIRM/MANUFACTURER:

Ortho-Clinical Diagnostics, Inc.

VOLUME:

3117 units (813 US, 2304 OUS)

DISTRIBUTION:

Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.